7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ODONTO TOOTHBRUSH
FDA 510(k)
FDA Class 1
·Dental
SURETEK MEDICAL REPROCESSED COMPRESSION SLEEVES
FDA 510(k)
FDA Class 2
·Cardiovascular
EDS Universal Cement
FDA 510(k)
FDA Class 2
·Dental
OT VERIO PRO PLUS METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·October 4, 2010
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·November 14, 2012
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 30, 2014